By Nicole Reifman
—

Last week, in Smith & Nephew, Inc. v. Rea, the
Federal Circuit reversed a decision of the Patent Trial and Appeal
Board, finding U.S. Patent No. 7,128,744 (the '744
patent), which is owned by Synthes, to be obvious.  Smith & Nephew originally
submitted a request for reexamination of the '744 patent, which was granted.  Upon review under reexamination, the Examiner
found all of the claims of the patent to be obvious.  Synthes appealed the Examiner's decision to the
Patent Trial and Appeal Board, which reversed the Examiner's decision with respect to certain
claims (claims 1-23 and 32).  Smith &
Nephew then appealed the Board's decision to the Federal Circuit.  Despite the
deferential standard of review (substantial evidence) to be applied for a
Board decision, the Federal Circuit found claims 1-23 and 32 to be
obvious.

Both parties and
the Court treated claim 1 as representative for all claims under appeal.  Claim 1 is related to a bone plating system designed
to improve the stability of a bone fracture in a long bone.  The claimed system includes a plate with a shaft
portion that runs along the outside of a fractured bone, and a flared head
portion to accommodate the wider portion of the bone near a joint.  Predrilled
holes are formed on both the shaft and the head portions of the plate.  The dispute in the case focused on the
structure of the holes in the head portion of the plate; in particular, whether it would have
been obvious at the time of the invention to design a bone plate in which all
of the holes in the plate's head portion were conically tapered and at least
partially threaded, as required by claim 1.

A number of prior
art references were applied.  First, the
Court found that a prior art Synthes condylar buttress plate disclosed most of
the limitations of claim 1 of the '744 patent, including a head portion of a
plate with at least three screw holes.  An
article by Kenneth Koval and an FDA submission by Synthes (dubbed the K982222
reference) each disclosed modifying the Synthes prior art plate to include
partially threaded holes to engage the threads on the head of a locking
screw.  A Synthes patent, U.S. Patent No.
5,709,686 (the '686 patent) disclosed anchor holes that were all partially
threaded and intended to accommodate either locking screws or compression
screws.  Another article, by N.P. Haas,
disclosed holes in the head portion of a plate that were both conically tapered
and partially threaded; however, unlike the other prior art plates, the Haas
plate merely stabilized the femur and did not contact, let alone, compress,
bone fragments directly.

The Board found
that these prior art references did not teach or suggest the exclusive use of
conical, partially threaded holes in a condylar buttress plate because it was
not believed that conical, partially threaded holes could be used with non-locking
(compression) screws to provide compression against a bone.  The Court held that the Board erred in its
analysis, since claim 1 of the '744 patent does not require that the screws
drilled into the head holes provide compression ("the patentability of the
invention . . . turns on the structure of the holes, not the special nature of the
non-locking screw"), and, contrary to Synthes' suggestion that compression is
needed in the head portion of the plate, the specification of the '744 patent
indicated that locking screws are sometimes used in all of the threaded holes
of the head portion of the plate.

The Court also found
the Board erred in determining the prior art showed that using a compression
screw in a conical, partially threaded hole would cause the screw to undesirably
protrude above the line of the plate.  The
Court pointed to a chamfer disclosed in the Haas reference that could be used
to countersink a screw head so that it does not sit above the top surface of
the plate.  The Board had disregarded
the Haas chamfer because a drawing in Haas showed the chamfer to be too narrow
to prevent protrusion of a compression screw.  The Court held that the Board erred in disregarding the Haas chamfer, and that the chamfer should
not be limited to the narrow one shown in the drawing, as chamfers are "conventional features in the art and can be sized to accommodate screw threads
of varying heights."  The Court also
reasoned that a person of ordinary skill in the art would not have necessarily
selected a "rounded-bottom head" that would stick out from the plate, but would
have chosen an appropriately shaped screw for the plate holes.

Finally, the Court
held that the Board erred in relying on distinguishing the partially threaded,
partly conical, holes discussed in the '686 patent from the fully conical
threaded holes in the Haas reference for obviousness.  The Court noted that the '744 patent discloses
that partially threaded holes, regardless of shape, could provide compression,
and held that "a person of skill could adjust a plate hole's geometry — whether
conical, cylindrical, or otherwise — to fit any standard screw without
sacrificing compression."

Thus, the Court
held that the motivation to combine the holes in the Haas reference with the
prior art condylar plates was there:  the use of threads in all of the holes
offers flexibility to the surgeon to choose either locking or non-locking
(compression) screws in any of the holes in the head portion of the plate.

The Court additionally
held that the Board should have considered two other prior art references that the Board had discounted because the Examiner had not relied on the references in making his rejections.  The
fact that the Examiner had incorporated Smith & Nephew's arguments by
reference (which included the two references) allowed for Board review of those
references.  The Court held that the two
references were "clearly probative" regarding whether it was known at the time
of the invention that non-locking screws could be used in threaded holes.

Thus, the Court,
despite taking a deferential approach to the Board's findings due to the substantial evidence standard of review, concluded that the Board erred in
its decision, and reversed the Board's decision for claims 1-23 and 32.  In addressing the deference owed
the Board, The Court noted that it did not dispute the Board's resolution of the factual
questions of the case, and that the Board's decision was "mainly the result of
the [Board's] analytical errors," as discussed above.

Smith &
Nephew, Inc. v. Rea (Fed. Cir. 2013)
Panel: Circuit
Judges Dyk, Bryson, and Wallach
Opinion by Circuit
Judge Bryson